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What is the impact of ICH on adverse reaction reporting in the frame of pharmacovigilance
The agreement on the specifications for the electronic
exchange of Individual Case Safety Reports (ICSRs) as a result of
ICH has changed the way of exchanging pharmacovigilance information.
The implementation of the ICH standards by all parties involved
will result in the replacement of paper reporting by a more efficient
and rapid electronic exchange of information and the capability of
regulators and pharmaceutical industry to use pharmacovigilance data
in a more standardised way.
The ultimate goal is that national Competent Authorities in the
EEA, and pharmaceutical companies extract ICSR data from their locally
established pharmacovigilance database and transmit these data electronically
in the internationally agreed format to one or many receivers where
the information can be automatically processed and evaluated
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Last update: Monday, 29 May 2006.
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